Sofosbuvir Plus Ravidasvir for the Treatment of HCV Chronic Infection
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ClinicalTrials.gov Identifier: NCT02961426 |
Recruitment Status
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Recruiting
First Posted
: November 11, 2016
Last Update Posted
: May 11, 2017
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Tracking Information | |||||||||
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First Submitted Date ICMJE | September 7, 2016 | ||||||||
First Posted Date ICMJE | November 11, 2016 | ||||||||
Last Update Posted Date | May 11, 2017 | ||||||||
Study Start Date ICMJE | September 2016 | ||||||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Sustained Virological Response 12 weeks post treatment completion (SVR12), as evidenced by HCV RNA level less than the lower limit of quantification of 15 IU/mL [ Time Frame: Outcome measure of sustained virological response will be assessed 12 weeks after the end of the treatment (SVR 12) as soon as the data will be available ] In case of positive HCV RNA, HCV sequences at base line and 12 weeks post treatment completion will be compared to rule out reinfection. Reinfections are not considered as failures
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT02961426 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Sofosbuvir Plus Ravidasvir for the Treatment of HCV Chronic Infection | ||||||||
Official Title ICMJE | Open Label Phase II/III, Multicenter, Trial to Assess the Efficacy, Safety, Tolerance, and Pharmacokinetics of Sofosbuvir Plus Ravidasvir in HCV (+/- HIV) Chronically Infected Adults With no or Compensated Cirrhosis in Thailand and Malaysia | ||||||||
Brief Summary | This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety, tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV infection. | ||||||||
Detailed Description | The study will assess the efficacy and safety of SOF-RDV across all genotypes, among non-cirrhotic and cirrhotic with CTP class A, interferon/ribavirin naïve or experienced, HCV mono-infected and HCV/HIV co-infected subjects. It will also study the pharmacokinetics of RDV and, in HCV/HIV co-infected subjects, possible drug-drug interactions with antiretrovirals. The treatment duration will be 12 weeks for subjects with no cirrhosis (Metavir F0 to F3) and 24 weeks for subjects with compensated cirrhosis (Metavir F4, CTP class A). After enrollment of the first 300 evaluable patients is complete, enrollment will pause while data is being accumulated and analyzed. After review of interim results by the independent Data and Safety Monitoring Board (DSMB), and by the study Steering Committee, enrollment will resume. Should modification of the study design be required upon interim analysis, decision will be taken by the study steering committee and the amended protocol or expanded protocol will be submitted to the Ethics Committee for approval. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatitis C | ||||||||
Intervention ICMJE | Drug: sofosbuvir
combination sofosbuvir ravidasvir treatment for non cirrhotic and compensated cirrhotic patients
Other Name: ravidasvir |
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Study Arms |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
750 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date | December 2018 | ||||||||
Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Positive anti-HCV antibody or detectable HCV RNA or HCV genotype at least 6 months before screening and HCV viral load ≥104 IU/mL at the time of screening In subjects without documented HCV test results 6 months before screening, chronic hepatitis C infection can be assumed if risk exposures occurred > 6 months prior to screening and HCV viral load ≥104 IU/mL at the time of screening.
Exclusion Criteria:
Evidence of advanced stage liver cirrhosis and Child-Turcotte-Pugh (CTP) Class B or C or CTP score >6) or current/past history of decompensation including ascites, variceal bleeding, spontaneous bacterial peritonitis, or hepatic encephalopathy.
Note: An electrocardiogram will be performed at screening and in case of doubt, the subject will be referred to a cardiologist for advice. Subjects will be instructed to immediately consult if they experience dizziness, light headedness or fainting spell. - HIV/HCV co-infected patients not yet on stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period. |
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Malaysia, Thailand | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02961426 | ||||||||
Other Study ID Numbers ICMJE | DNDi-SOF/RDV-01-HCV | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement |
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Responsible Party | Drugs for Neglected Diseases | ||||||||
Study Sponsor ICMJE | Drugs for Neglected Diseases | ||||||||
Collaborators ICMJE | Ministry of Health, Malaysia | ||||||||
Investigators ICMJE |
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PRS Account | Drugs for Neglected Diseases | ||||||||
Verification Date | May 2017 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |